Duns Number:536935331
Device Description: The basis is part of the container which product number is 188202ND and that is used for t The basis is part of the container which product number is 188202ND and that is used for transport and sterilization of instruments and non sterile implants.
Catalog Number
-
Brand Name
ADVANSYS®
Version/Model Number
188212ND
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FSM
Product Code Name
TRAY, SURGICAL, INSTRUMENT
Public Device Record Key
aaa5e389-ae00-4a22-b91b-84066a4b0ee9
Public Version Date
July 08, 2021
Public Version Number
5
DI Record Publish Date
May 26, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |